Head Engineering Information, Compliance & CQV

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Job Description

OBJECTIVES/PURPOSE

·  Lead the Engineering Information & Compliance function within the GCC and ensure the development of consistent, compliant, and high-quality engineering information, qualification frameworks, and compliance standards across the GCC-supported Global Design Engineering project portfolio.

·  Build and develop organizational capability, technical expertise, leadership pipelines, and resource capacity across CQV & Compliance Engineering and Engineering Information Management.

·  Drive engineering excellence, standardization, compliance, digitalization, and continuous improvement through lifecycle-focused information and compliance management practices.

·  Ensure engineering deliverables, qualification frameworks, and engineering information support GMP, quality, regulatory, data integrity, and business requirements.

Accountabilities

Functional Leadership

• Lead and develop Engineering Information & Compliance teams and Design Leads.
• Establish workforce planning, capability development, succession planning, and talent strategies.
• Support recruitment, onboarding, engagement, and retention of engineering and compliance talent.
• Foster a culture of quality, compliance, collaboration, innovation, and continuous learning.

Engineering Information & Compliance Expertise

• Provide expertise for engineering information management, qualification readiness, validation frameworks, and compliance methodologies.
• Establish and maintain standards, templates, procedures, and best practices supporting engineering and qualification activities.
• Drive consistency of engineering information, deliverables, qualification documentation, and compliance expectations across projects.
• Support lifecycle management of engineering data, documentation, and compliance artefacts.

Quality, Compliance & Governance

• Ensure alignment with GMP requirements, Data Integrity principles, Takeda standards, and applicable industry regulations.
• Ensure practices align with ASTM E2500, GAMP5, CFR Part 11, and applicable regulatory requirements.
• Oversee governance activities, risk assessments, audits, lessons learned, and inspection readiness support.
• Drive standardization and technical quality assurance of engineering and qualification deliverables across engineering deliverables and compliance frameworks.

Innovation & Continuous Improvement

• Promote digital information management and data-driven compliance practices.
• Drive standardization, automation, and reuse of templates, procedures, and engineering information.
• Support continuous improvement of lifecycle documentation, qualification methodologies, and engineering information quality.
• Identify opportunities to improve efficiency, compliance, traceability, and engineering effectiveness.

Stakeholder Management

• Act as the primary GCC point of contact for Engineering Information and Compliance capabilities.
• Collaborate with Design Engineering, Quality, Manufacturing, Project Teams, Digital Manufacturing, other Takeda Global functional groups, and Site stakeholders.
• Support enterprise initiatives related to compliance readiness, information governance, and engineering excellence.
• Partner with projects and sites to ensure consistent application of engineering information and qualification standards.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

Education

• Bachelor's Degree in Engineering, Quality, Life Sciences, Information Management, Pharmaceutical Sciences, or related discipline.
• Master's Degree preferred.

Experience

• 15+ years of experience in pharmaceutical engineering, qualification, validation, compliance, engineering information management, or related disciplines.
• Experience supporting GMP-regulated facilities and capital projects.
• Experience leading multidisciplinary organizations and capability-building initiatives.
• Experience developing governance frameworks, standards, templates, and lifecycle management processes.

Behavioral Competencies

• Strategic leadership and organizational development.
• People leadership and talent management.
• Stakeholder engagement and influencing skills.
• Quality and compliance mindset.
• Innovation and digital mindset.
• Continuous improvement mindset.
• Strong communication and decision-making capabilities.

Technical Skills

• GMP compliance and regulatory requirements.
• ASTM E2500 and risk-based qualification principles.
• Validation and qualification frameworks. Kneat and or other paperless validation systems.
• Engineering information and document governance.
• Data Integrity and lifecycle management.
• Engineering data management and reporting.
• GAMP5 and computerized systems compliance.
• Digital information management and governance platforms.

Locations

Worker Type

Worker Sub-Type

Time Type